The analytical phase of formal GLP studies needs to be performed according to the OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring.
Lablytica is part of the Swedish accreditation body’s (SWEDAC) OECD compliance and inspection program. The analytical project phases of pre-clinical animal studies performed at Lablytica are regularly inspected by SWEDAC.
Bioanalysis of PK samples
The bioanalysis of PK samples from pre-clinical animal studies needs to be performed using validated bioanalytical methods and an adherence to the current OECD GLP as well as EMA/FDA guidelines for the analysis of study samples. Lablytica supports the bioanalytical phase of pre-clinical studies with an experienced team of Analytical Chemists, Principal Investigator as well as a Quality Assurance group. These analytical phases are performed in compliance with the OECD Good Laboratory Practice (GLP) standards.
Non-Clinical Dose Formulation Analysis (NCDFA)
In formal GLP studies the drug product (DP) administered to the animals needs to be analysed and quantified using a validated analytical method. Since there is a large variety of formulation technologies available ranging from solids to solutions, suppositories and suspensions, the analytical methods also need to reflect this variation.
Lablytica has extensive experience in developing, setting-up and validating bioanalytical and analytical methods for animal plasma and urine PK samples as well as for Non-Clinical Dose Formulations. These methods can comprise a transfer of an existing, validated method, or, alternatively, we can develop a method in-house for your analyte right from the start.